Federal Register / Vol. 76, No. 5 / Friday, January 7, 2011 / Notices 1183 

1http://www.fda.gov/RegulatoryInformation/ 

Guidances/ucm125505.htm. 

Drugs.’’ This public workshop is 

intended to provide a forum for 

discussing potential approaches toward 

a track and trace system and obtaining 

input from supply chain partners on 

attributes and standards for the 

identification, authentication, and 

tracking and tracing of prescription drug 

packages, and to further the Agency’s 

goal of protecting public health by 

securing the drug supply chain against 

the introduction of counterfeit and other 

substandard drugs. 

DATES: The public workshop will be 

held on February 15 and 16, 2011, from 

9 a.m. to 5 p.m. Submit electronic or 

written comments on the posted 

information or on the workshop to the 

docket by April 16, 2011. 

ADDRESSES: The public workshop will 

be held at FDA’s White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31, 

room 1503, Silver Spring, MD 20993. To 

register for the public meeting, e-mail 

your registration information to 

drug.trackandtrace@fda.hhs.gov. See 

section III of this document for 

registration details. Submit electronic 

comments to http:// 

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in the brackets in 

the heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Connie Jung, Office of the 

Commissioner, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993, 301– 

796–4830, e-mail: 

connie.jung@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Since the formation of the first 

Counterfeit Drug Task Force in 2003, 

FDA has strongly advocated for a multilayered approach to securing the supply 

chain and protecting consumers from 

the threats posed by counterfeit drugs. 

The ability to track and trace finished 

drug products in the supply chain plays 

a significant role in providing 

transparency and accountability in the 

drug supply chain. On September 27, 

2007, the Food and Drug Administration 

Amendments Act of 2007 (FDAAA) 

(Pub. L. 110–85) was signed into law. 

Section 913 of this legislation created 

section 505D of the Federal Food, Drug, 

and Cosmetic Act (the FD&C Act), 

which requires the Secretary of Health 

and Human Services (the Secretary) to 

develop standards and identify and 

validate effective technologies for the 

purpose of securing the drug supply 

chain against counterfeit, diverted, 

subpotent, substandard, adulterated, 

misbranded, or expired drugs. In 

addition, section 505D of the FD&C Act 

directs the Secretary to consult with 

specific entities to prioritize and 

develop standards for identification, 

validation, authentication, and tracking 

and tracing of prescription drugs. 

In March 2010, FDA issued a final 

guidance for industry which describes 

the Agency’s current recommendation 

for standardized numerical 

identification (also known as 

serialization) for prescription drug 

packages (Standards for Securing the 

Drug Supply Chain—Standardized 

Numerical Identification for 

Prescription Drug Packages, Guidance 

for Industry—Final Guidance 1). This 

guidance is intended to be the first of 

several steps that FDA may take to 

implement section 505D of the FD&C 

Act and further improve the security of 

the drug supply chain. As FDA 

continues to work on developing 

additional standards for securing the 

drug supply chain, the agency is seeking 

public input to ensure that we consider 

information regarding all supply chain 

participants. 

II. Purpose of the Workshop 

This public workshop is intended to 

explore approaches for achieving an 

effective and feasible track and trace 

system for finished prescription drug 

products from the supply chain 

stakeholder’s point of view, including 

industry and the public, and to obtain 

views on system attributes and 

standards that would facilitate 

identification, authentication, and 

tracking and tracing of prescription drug 

packages. We intend to discuss with 

stakeholders the necessary elements to 

accomplish effective authentication and 

identify desirable features of a track and 

trace system. Participants will not be 

asked to develop consensus opinions 

during the discussion, but rather to 

provide their individual perspectives. 

By February 4, 2011, FDA will post 

information on our Web site (http:// 

www.fda.gov/Drugs/DrugSafety/ 

ucm169828.htm) under ‘‘Standards 

Development for Prescription Drug 

Supply Chain Security.’’ as follows: 

• Workshop agenda, 

• Workshop discussion topics. 

III. How To Register for the Workshop 

To register for the workshop either: 

(1) E-mail your registration information 

to drug.trackandtrace@fda.hhs.gov or 

(2) mail your registration information to 

the contact person (see FOR FURTHER

INFORMATION CONTACT). Registration 

information should include registrant 

name, company or organization, 

address, phone number, and email 

address. Registration requests should be 

received by February 1, 2011. 

Registration is free. Seats are limited. 

FDA may limit the numbers of 

participants from each organization 

based on space limitations. Registrants 

will receive confirmation upon 

acceptance for participation in the 

workshop. Onsite registration on the 

day of the meeting will be based on 

space availability on the day of the 

event starting at 8 a.m. If registration 

reaches maximum capacity, FDA will 

post a notice closing meeting 

registration for the workshop on FDA’s 

Web site at: http://www.fda.gov/Drugs/ 

DrugSafety/ucm169828.htm. If you need 

special accommodations due to a 

disability, please contact Connie Jung 

(see FOR FURTHER INFORMATION CONTACT) 

at least 7 days in advance. 

IV. Parking Information 

If you are driving to FDA’s White Oak 

Campus, you should proceed to the 

South East Surface Parking Lot to park 

your vehicle. Shuttle service is available 

from the bus shelters in the South East 

Lot to Building 1. The FDA campus is 

a Federal facility, therefore all meeting 

attendees must enter through Building 1 

and follow security procedures. 

Dated: January 3, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–72 Filed 1–6–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

Periodically, the Health Resources 

and Services Administration (HRSA) 

publishes abstracts of information 

collection requests under review by the 

Office of Management and Budget 

(OMB), in compliance with the 

Paperwork Reduction Act of 1995 (44 

U.S.C. Chapter 35). To request a copy of 

the clearance requests submitted to 

OMB for review, call the HRSA Reports 

Clearance Office on (301) 443–1129. 

The following request has been 

submitted to the OMB for review under 

the Paperwork Reduction Act of 1995: 


jdjones on DSK8KYBLC1PROD with NOTICES
1184 Federal Register / Vol. 76, No. 5 / Friday, January 7, 2011 / Notices 

Proposed Project: Ryan White HIV/ 

AIDS Program: Client-Level Data 

Reporting System: (OMB No. 0915– 

0323)—[Revision] 

The Ryan White HIV/AIDS Program’s 

client-level data reporting system, 

entitled the Ryan White HIV/AIDS 

Program Services Report or the Ryan 

White Services Report (RSR), was 

created in 2008 by the Health Resources 

and Services Administration (HRSA). It 

is designed to collect information from 

grantees, as well as their subcontracted 

services providers, funded under Parts 

A, B, C, and D, and the Part F Minority 

AIDS Initiative of the Ryan White HIV/ 

AIDS Treatment Extension Act of 2009 

(Ryan White HIV/AIDS Program). The 

Ryan White HIV/AIDS Program 

provides Federal HIV/AIDS Programs in 

the Public Health Service (PHS) Act 

under Title XXVI with flexibility to 

respond effectively to the changing HIV 

epidemic, with an emphasis on 

providing life-saving and life-extending 

services for people living with HIV/ 

AIDS across this country, as well as 

targeting resources to areas that have the 

greatest needs. 

All parts of the Ryan White HIV/AIDS 

Program specify HRSA’s responsibilities 

in the administration of grant funds, the 

allocation of funds, the evaluation of 

programs for the population served, and 

the improvement of the quality of care. 

Accurate records of the providers 

receiving Ryan White HIV/AIDS 

Program funding, the services provided, 

and the clients served, continue to be 

critical issues for the implementation of 

the legislation and are necessary for 

HRSA to fulfill its responsibilities. 

The RSR provides data on the 

characteristics of Ryan White HIV/AIDS 

Program-funded grantees, their 

contracted service providers, and the 

clients being served with program 

funds. The Report is intended to 

support clinical quality management, 

performance measurement, service 

delivery, and client monitoring at the 

system and client levels. The reporting 

system consists of two online data 

forms, the Grantee Report and the 

Service Provider Report, as well as a 

data file containing the client-level data 

elements. Data are submitted annually. 

The legislation specifies grantee 

accountability and linking performance 

to budget. The RSR is used to ensure 

compliance with the requirements of the 

legislation, to evaluate the progress of 

programs, to monitor grantee and 

provider performance, to measure the 

Government Performance and Results 

Act (GPRA) and the Performance 

Assessment Rating Tool (PART) goals, 

and to meet reporting responsibilities to 

the Department, Congress, and OMB. 

In addition to meeting the goal of 

accountability to Congress, clients, 

advocacy groups, and the general 

public, information collected through 

the RSR is critical for HRSA, State and 

local grantees, and individual providers 

to assess the status of existing HIVrelated service delivery systems to 

investigate trends in service utilization 

and to identify areas of greatest need. 

The estimated average annualized 

hour burden is 17,975 hours per year. 

Burden estimates are broken down into 

burden to grantee respondents and 

burden to service provider respondents. 

Estimates for grantees and service 

providers are further divided by the RSR 

component. Estimates for grantees and 

providers are based on prior experience 

in collecting, maintaining, and reporting 

data using the RSR and interviews with 

volunteers from grantee agencies. 

The response burden for grantees is 

estimated as: 

Component Source of funding Number of 

respondents 

Responses 

per grantee 

Hours per 

response 

Total hour 

burden 

Grantee Report ................................. Part A ............................................... 56 1 2.04 114 

Part B ............................................... 59 1 2.52 149 

Part C ............................................... 354 1 0.32 113 

Part D ............................................... 98 1 0.33 32 

Subtotal ..................................... 567 ........................ ........................ 408 

The response burden for service 

providers is estimated as: 

Component Number of 

respondents 

Responses 

per provider 

Total 

responses 

Hours per 

response 

Total hour 

burden 

Service Provider Report .................... * 2,080 .............................................. 1 * 2,080 2.30 4,784 

* All providers, including providers of administrative support services and direct client services. 

Component Electronic data system Number of 

respondents 

Responses 

per provider 

Total 

responses 

Hours per 

response 

Total hour 

burden 

Client Report ....................... No ....................................... 56 1 56 106.25 5,950 

Yes ..................................... 1,822 1 1,822 3.75 6,832.5 

Subtotal ....................... ** 1,878 ........................ ** 1,878 ........................ 12,783 

** Providers of direct client services only. 

Total Burden is 17,975. 

Written comments and 

recommendations concerning the 

proposed information collection should 

be sent within 30 days of this Federal 

Register Notice to the desk officer for 

HRSA, either by e-mail to OIRA— 

submission@omb.eop.gov or by fax to 

202–395–6974. Please direct all 

correspondence to the ‘‘attention of the 

desk officer for HRSA.’’ 

Dated: January 3, 2011. 

Robert Hendricks, 

Director, Division of Policy and Information 

Coordination. 

[FR Doc. 2011–99 Filed 1–6–11; 8:45 am] 

BILLING CODE 4165–15–P 


jdjones on DSK8KYBLC1PROD with NOTICES